A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.
A 2x2 randomised factorial SWAT of the use of a pen and small, financial incentive to improve recruitment in a randomised controlled trial of yoga for older adults with multimorbidity.
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DOI：
10.12688/f1000research.52164.2
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发表时间：
2021
期刊：
影响因子：
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通讯作者：
Tew GA
中科院分区：
文献类型：
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作者：
Fairhurst C;Roche J;Bissell L;Hewitt C;Hugill-Jones J;Howsam J;Maturana CS;Corbacho Martin B;Paul SS;Rose F;Torgerson DJ;Ward L;Wiley L;Tew GA
背景：货币和其他激励措施可能会增加随机对照试验的招募。方法：2x2因子“试验中的研究”，包括一支笔和/或5英镑（英镑）现金和邮寄招募包，以增加随机进入宿主试验（“温柔岁月瑜伽”）的参与者人数。次要结局：筛查形式的复诊和复诊时间，以及每增加一名随机参与者的费用。二元数据采用logistic回归分析，回归时间采用Cox比例风险回归分析。结果：818名潜在宿主试验参与者被纳入。在送笔组（n=409）和未送笔组（n=409）之间，没有证据表明随机参与者的比例有差异(15人（3.7%）vs 11人（2.7%）；OR 1.38, 95% CI 0.63-3.04)，返回筛查表(66例（16.1%）对61例（14.9%）；OR 1.10, 95% CI 0.75-1.61)未能及时返回筛查表（HR 1.09, 95% CI 0.77-1.55）。在那些收到5英镑（n=409）和没有收到5英镑（n=409）的人之间，没有证据表明随机性增加了(14人（3.4%）对12人（2.9%）；OR 1.18, 95% CI 0.54-2.57)，但返回的筛查表格更多(77（18.8%）对50 (12.2%)；OR 1.67, 95% CI 1.13-2.45)，返回筛查表的时间缩短（HR 1.56, 95% CI 1.09-2.22）。干预之间没有观察到显著的相互作用。每增加一名随机参与者，笔和笔的成本分别为32英镑和1000英镑和5英镑。结论：小额的金钱激励并没有导致更多的参与者被随机分配到宿主试验中，但确实鼓励了对招募邀请的更多和更快的反应。由于成本相对较高，我们不建议使用这种干预措施来增加这一人群的招募。钢笔更便宜，但没有证据表明它有益。
Background: Monetary and other incentives may increase recruitment to randomised controlled trials. Methods: 2x2 factorial ‘study within a trial’ of including a pen and/or £5 (GBP) in cash with a postal recruitment pack to increase the number of participants randomised into the host trial (‘Gentle Years Yoga’) for older adults with multimorbidity. Secondary outcomes: return, and time to return, of screening form, and the cost per additional participant randomised. Binary data were analysed using logistic regression and time to return using Cox proportional hazards regression. Results: 818 potential host trial participants were included. Between those sent a pen (n=409) and not sent a pen (n=409), there was no evidence of a difference in the proportion of participants randomised (15 (3.7%) versus 11 (2.7%); OR 1.38, 95% CI 0.63–3.04), in returning a screening form (66 (16.1%) versus 61 (14.9%); OR 1.10, 95% CI 0.75–1.61) nor in time to return the screening form (HR 1.09, 95% CI 0.77–1.55). Between those sent £5 (n=409) and not sent £5 (n=409), there was no evidence of increased randomisation (14 (3.4%) versus 12 (2.9%); OR 1.18, 95% CI 0.54–2.57), but more screening forms were returned (77 (18.8%) versus 50 (12.2%); OR 1.67, 95% CI 1.13–2.45) and there was decreased time to return screening form (HR 1.56, 95% CI 1.09–2.22). No significant interaction between the interventions was observed. The cost per additional participant randomised was £32 and £1000 for the pen and £5, respectively. Conclusion: A small, monetary incentive did not result in more participants being randomised into the host trial but did encourage increased and faster response to the recruitment invitation. Since it is relatively costly, we do not recommend this intervention for use to increase recruitment in this population. Pens were cheaper but did not provide evidence of benefit.